PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK (CCP-UK) CASE REPORT FORMS FRONT PAGE 1 of 3
v96 06JULY2020
DESIGN OF THE CCP-UK CASE REPORT FORM (CRF)
This CRF is divided into a ldquoADMISSIONrdquo form (4 pages) a ldquoDAILYrdquo form (2 pages) for daily clinical and laboratory and data an ldquoOUTCOMErdquo form (4 pages) and a ldquoWITHDRAWALrdquo form (1 page) HOW TO USE THIS CRF The CRF is designed to complement the Tier of activity that a site has capacity and capability to work to This is likely to vary over the course of an outbreak The decision on which Tier to use is up to the Local Principal Investigator All high-quality data is valuable for analysis Ideally data and samples will be collected with consent using Tier 2 of the protocol schedule as outlined below This will be of greatest public health research value in the early stages of an outbreak Data can be collected as Tier Zero activity regardless of consent including retrospectively and from deceased cases Consent must be obtained for any biological sampling at Tier 1 and Tier 2 activity
Tier Zero For sites where caseload or facilities limit research capacity to deliver Tier 1 or Tier 2 activity OR For collection of data without consent from any case current past and deceased Please complete the ADMISSION CRF and DAILY CRF for the first day of hospital admission (day 1) the DAILY CRF again for the first day of any ICU admission then the OUTCOME CRF at day 28 discharge or death (whichever occurs first) NB For patients receiving Remdesivir (RDV) and IL6 inhibitors please complete an extra DAILY CRF for first day that such a drug is dosed and for day 14 after drug initiation (if patient remains admitted) Collection of this data is requested by the CMOs in all nations
Tier 1 For sites where facilities limit research capacity to deliver Tier 2 activity or where consent is only for single timepoint biological sampling Please complete the ADMISSION CRF and DAILY CRF for the first day of hospital admission (day 1) the DAILY CRF for the third (d3) sixth (d6) and ninth (d9) days the DAILY CRF again for the first day of any ICU admission and then the OUTCOME CRF at day 28 discharge or death (whichever occurs first) NB For patients receiving Remdesivir (RDV) and IL6 inhibitors please complete an extra DAILY CRF for first day that such a drug is dosed and for day 14 after drug initiation (if patient remains admitted) Collection of this data is requested by the CMOs in all nations
Tier 2 For sites with available resources to deliver Tier 2 activity per the protocol schedule With consent for multiple timepoint biological sampling
Please complete the ADMISSION CRF and DAILY CRF for the first day of hospital admission (day 1) the DAILY CRF for the third (d3) sixth (d6) and ninth (d9) days the DAILY CRF again for the first day of any ICU admission and then the OUTCOME CRF at day 28 discharge or death whichever occurs first If biological sampling for research purposes occurs outside of the CRF occurs NB For patients receiving Remdesivir (RDV) and IL6 inhibitors please complete an extra DAILY CRF for first day that such a drug is dosed and for day 14 after drug initiation (if patient remains admitted) Collection of this data is requested by the CMOs in all nations
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
Example R B S 2 5 -- 0 0 1 6 On each page above here write site code amp participant number as per this
CASE REPORT FORMS FRONT PAGE 2 of 3
GENERAL GUIDANCE
bull The CRF is designed to collect data obtained through examination interview and review of hospital
notes Data may be collected retrospectively if the patient is enrolled after the admission date or
deceased after admission
bull Participant Identification Numbers consist of a 5-digit CPMS ODS site code and a 4-digit participant
number You should obtain a site code by contacting your local RampD office or CCPliverpoolacuk
Participant numbers should be assigned sequentially for each site beginning with 0001 In the case of
a single site recruiting participants on different wards or where it is otherwise difficult to assign
sequential numbers it is acceptable to assign numbers in blocks Eg Ward X will assign numbers
from 0001 onwards and Ward Y will assign numbers from 5001 onwards Enter the Participant
Identification Number at the top of every page
bull CRF data should be entered to the central database at httpsncovmedscioxacuk
bull REDCap registration access is obtained by contacting CCPREDCapliverpoolacuk
bull Please contact us at CCPREDCapliverpoolacuk for help with database problems
RULES DEFINING DAYS 1 Day of Admission = Day of Admission regardless eg even if admitted 2 months ago for a broken
hip
2 For Community Acquired COVID-19 ie admitted with symptoms consistent with COVID-19 day 1
= first 24 hours of admission
3 For those who are already admitted for any other reason and who subsequently test positive day
1 = day the positive COVID-19 test was collected
4 Rules 2 and 3 are important but we recognise that start of biological sampling for Tier 1 and 2
may be deferred or delayed for several reasons eg due to a delay in the COVID-19 result being
reported If this happens please take the d1 sample set as soon as possible and then d3 and d9
according to schedule or as close as possible
5 For Tier Zero date of enrolment is date on which the act of data collection started (no consent)
For Tier 1 amp 2 date of enrolment is enrolment = date of consent
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
CASE REPORT FORMS FRONT PAGE 3 of 3
Complete every line of every section except for where the instructions say to skip a section based on
certain responses
Selections with square boxes () are single selection answers (choose one answer only) Selections
with circles (o) are multiple selection answers (choose as many answers as are applicable)
Some fields are considered URGENT AND ESSENTIAL These are marked BOLD AND UNDERLINED
IN ALL CIRCUMSTANCES PLEASE PRIORITISE THESE DATA POINTS FOR URGENT UPLOAD
Mark lsquoNKrsquo for any results of laboratory values that are not known or not available
Avoid recording data outside of the dedicated areas Sections are available for recording additional
information
We recommend writing clearly in black ink using BLOCK-CAPITAL LETTERS
Place an (X) when you choose the corresponding answer To make corrections strike through (-------)
the data you wish to delete and write the correct data above it Please initial and date all corrections
In the case of a participant transferring between study sites such as to a Nightingale Hospital or
other surge facility it is preferred to maintain the same Participant Identification Number across the
sites When this is not possible a new Participant Identification Number should be assigned the
transferred participant will be linked by their identifiable data
Please keep all of the sheets for a single participant together eg with a staple or participant-unique
folder
These three FRONT PAGES do not need to be retained
DO NOT SEND CRFs to anyone by email or post
See the training guide on how to send consent to CCPliverpoolacuk using [SECURE] encryption
The Dalhousie University Clinical Frailty Score is provided below for your reference
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK ADMISSION FORM page 1 of 4 Date of enrolment [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Site Location__________________________________
For Tier Zero date of enrolment is date on which the act of data collection started For Tier 1 amp 2 enrolment = date of consent
CLINICAL INCLUSION CRITERIA
Proven or high likelihood of infection with pathogen of Public Health Interest YES NO NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Experience of the following symptoms during this illness episode (one or more required for inclusion)
History of self-reported feverishness or measured fever of ge 38oC YES NO
Cough YES NO
Dyspnoea (shortness of breath) OR Tachypnoea YES NO
Clinical suspicion of Acute Respiratory Infection despite not meeting criteria above YES NO respiratory rate ge50 breathsmin for lt1 year ge40 breathsmin for 1-4 years ge30 breathsmin for 5-12 years ge20 breathsmin for ge13 years
NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Adult or child who meets Case Definition for Inflammatory Multi-system Syndrome YES NO NB This group should be recruited regardless of covid-19 test as this syndrome can occur after mild disease in the community which has gone untested
DEMOGRAPHICS
Sex at Birth Male Female Not specified Date of birth [_D_][_D_][_M_][_M_][_ Y _][_ Y _][_Y_][_Y_] If date of birth is Not Known (NK) record Age [___][___][___]years OR [___][___]months Postcode [___][___][___][___] [___][___][___] England amp Wales NHS number Scotland CHI [___][___][___] [___][___][___] [___][___][___][___] NB Northern Ireland Health amp Care Number is not being collected at this time
Ethnic group (check all that apply)
oArab oBlack oEast Asian oSouth Asian oWest Asian oLatin American oWhite oAboriginalFirst Nations
oOther ________________________ NK
Employed as a Healthcare Worker YES NO NK
Pregnant YES NO NK If YES Gestational weeks assessment [___][___] weeks POST PARTUM (within six weeks of delivery) YES NO or NK (skip this section - go to INFANT)
Pregnancy Outcome Live birth Still birth Delivery date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Has infant(s) been tested for Motherrsquos infection YES NO NK If YES Positive Negative
IF POSITIVE PLEASE COMPLETE A SEPARATE CASE REPORT FORM FOR THE INFANT(s)
INFANT ndash Less than 1 year old YES NO (skip this section) Birth weight [___][___]kg NK
Gestational Term birth (ge37wk GA) Preterm birth (lt37wk GA) if lt37wk Estimated gestation ________weeks NK
Breastfed YES NO NK If YES Currently breastfed Breastfeeding discontinued NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 2 of 4
ONSET AND ADMISSION
Symptom onset date of firstearliest symptom [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] OR Asymptomatic
Admission date at this facility [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Is the patient being readmitted with Covid-19 YES NO NK
Please provide reason for readmission _____________________________________________________________ NK
Is this a NIGHTINGALE or other SURGE FACILITY YES NO NK
Transfer from other facility YES-other facility is a study site YES-other facility is not a study site NO NK
If YES Name of transfer facility____________________________________________ NK
If YES Admission date at previous facility (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If YES-Study Site Participant ID at previous facility I__I I__I I__I I__I I__I -- I__I I__I I__I I__I
OR Same as above
VITAL SIGNS AT HOSPITAL ADMISSION (first available data at presentationAdmission ndash within 24 hours)
Temperature [_ ][_ ][_ ]degC HR [_ ][_ ][_ ]beats per minute RR [_ ][_ ]breaths per minute
Systolic BP [_ ] [_ ] [_ ]mmHg Diastolic BP [_ ][_ ][_ ]mmHg Severe dehydration YES NO NK
Sternal capillary refill time gt2seconds YES NO NK
Oxygen saturation [_ ][_ ][_ ] On Room air Any Oxygen therapy NK
Admission signs and symptoms (observedreported at admission and associated with this episode of acute illness)
History of fever
Cough
with sputum production
bloody sputumhaemoptysis
Sore throat
Runny nose (Rhinorrhoea)
Ear pain
Wheezing
Chest pain
Muscle aches (Myalgia)
Joint pain (Arthralgia)
Fatigue Malaise
Shortness of breath (Dyspnoea)
Disturbance or loss of taste (Ageusia )
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
Lower chest wall indrawing
Headache
Altered consciousnessconfusion
Seizures
Abdominal pain
Vomiting Nausea
Diarrhoea
Conjunctivitis
Skin rash
Skin ulcers
Lymphadenopathy
Bleeding (Haemorrhage)
If Bleeding specify site(s)
Disturbance or loss of smell (Anosmia)
None
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
________________________
YES NO NK
YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
Example R B S 2 5 -- 0 0 1 6 On each page above here write site code amp participant number as per this
CASE REPORT FORMS FRONT PAGE 2 of 3
GENERAL GUIDANCE
bull The CRF is designed to collect data obtained through examination interview and review of hospital
notes Data may be collected retrospectively if the patient is enrolled after the admission date or
deceased after admission
bull Participant Identification Numbers consist of a 5-digit CPMS ODS site code and a 4-digit participant
number You should obtain a site code by contacting your local RampD office or CCPliverpoolacuk
Participant numbers should be assigned sequentially for each site beginning with 0001 In the case of
a single site recruiting participants on different wards or where it is otherwise difficult to assign
sequential numbers it is acceptable to assign numbers in blocks Eg Ward X will assign numbers
from 0001 onwards and Ward Y will assign numbers from 5001 onwards Enter the Participant
Identification Number at the top of every page
bull CRF data should be entered to the central database at httpsncovmedscioxacuk
bull REDCap registration access is obtained by contacting CCPREDCapliverpoolacuk
bull Please contact us at CCPREDCapliverpoolacuk for help with database problems
RULES DEFINING DAYS 1 Day of Admission = Day of Admission regardless eg even if admitted 2 months ago for a broken
hip
2 For Community Acquired COVID-19 ie admitted with symptoms consistent with COVID-19 day 1
= first 24 hours of admission
3 For those who are already admitted for any other reason and who subsequently test positive day
1 = day the positive COVID-19 test was collected
4 Rules 2 and 3 are important but we recognise that start of biological sampling for Tier 1 and 2
may be deferred or delayed for several reasons eg due to a delay in the COVID-19 result being
reported If this happens please take the d1 sample set as soon as possible and then d3 and d9
according to schedule or as close as possible
5 For Tier Zero date of enrolment is date on which the act of data collection started (no consent)
For Tier 1 amp 2 date of enrolment is enrolment = date of consent
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
CASE REPORT FORMS FRONT PAGE 3 of 3
Complete every line of every section except for where the instructions say to skip a section based on
certain responses
Selections with square boxes () are single selection answers (choose one answer only) Selections
with circles (o) are multiple selection answers (choose as many answers as are applicable)
Some fields are considered URGENT AND ESSENTIAL These are marked BOLD AND UNDERLINED
IN ALL CIRCUMSTANCES PLEASE PRIORITISE THESE DATA POINTS FOR URGENT UPLOAD
Mark lsquoNKrsquo for any results of laboratory values that are not known or not available
Avoid recording data outside of the dedicated areas Sections are available for recording additional
information
We recommend writing clearly in black ink using BLOCK-CAPITAL LETTERS
Place an (X) when you choose the corresponding answer To make corrections strike through (-------)
the data you wish to delete and write the correct data above it Please initial and date all corrections
In the case of a participant transferring between study sites such as to a Nightingale Hospital or
other surge facility it is preferred to maintain the same Participant Identification Number across the
sites When this is not possible a new Participant Identification Number should be assigned the
transferred participant will be linked by their identifiable data
Please keep all of the sheets for a single participant together eg with a staple or participant-unique
folder
These three FRONT PAGES do not need to be retained
DO NOT SEND CRFs to anyone by email or post
See the training guide on how to send consent to CCPliverpoolacuk using [SECURE] encryption
The Dalhousie University Clinical Frailty Score is provided below for your reference
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK ADMISSION FORM page 1 of 4 Date of enrolment [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Site Location__________________________________
For Tier Zero date of enrolment is date on which the act of data collection started For Tier 1 amp 2 enrolment = date of consent
CLINICAL INCLUSION CRITERIA
Proven or high likelihood of infection with pathogen of Public Health Interest YES NO NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Experience of the following symptoms during this illness episode (one or more required for inclusion)
History of self-reported feverishness or measured fever of ge 38oC YES NO
Cough YES NO
Dyspnoea (shortness of breath) OR Tachypnoea YES NO
Clinical suspicion of Acute Respiratory Infection despite not meeting criteria above YES NO respiratory rate ge50 breathsmin for lt1 year ge40 breathsmin for 1-4 years ge30 breathsmin for 5-12 years ge20 breathsmin for ge13 years
NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Adult or child who meets Case Definition for Inflammatory Multi-system Syndrome YES NO NB This group should be recruited regardless of covid-19 test as this syndrome can occur after mild disease in the community which has gone untested
DEMOGRAPHICS
Sex at Birth Male Female Not specified Date of birth [_D_][_D_][_M_][_M_][_ Y _][_ Y _][_Y_][_Y_] If date of birth is Not Known (NK) record Age [___][___][___]years OR [___][___]months Postcode [___][___][___][___] [___][___][___] England amp Wales NHS number Scotland CHI [___][___][___] [___][___][___] [___][___][___][___] NB Northern Ireland Health amp Care Number is not being collected at this time
Ethnic group (check all that apply)
oArab oBlack oEast Asian oSouth Asian oWest Asian oLatin American oWhite oAboriginalFirst Nations
oOther ________________________ NK
Employed as a Healthcare Worker YES NO NK
Pregnant YES NO NK If YES Gestational weeks assessment [___][___] weeks POST PARTUM (within six weeks of delivery) YES NO or NK (skip this section - go to INFANT)
Pregnancy Outcome Live birth Still birth Delivery date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Has infant(s) been tested for Motherrsquos infection YES NO NK If YES Positive Negative
IF POSITIVE PLEASE COMPLETE A SEPARATE CASE REPORT FORM FOR THE INFANT(s)
INFANT ndash Less than 1 year old YES NO (skip this section) Birth weight [___][___]kg NK
Gestational Term birth (ge37wk GA) Preterm birth (lt37wk GA) if lt37wk Estimated gestation ________weeks NK
Breastfed YES NO NK If YES Currently breastfed Breastfeeding discontinued NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 2 of 4
ONSET AND ADMISSION
Symptom onset date of firstearliest symptom [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] OR Asymptomatic
Admission date at this facility [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Is the patient being readmitted with Covid-19 YES NO NK
Please provide reason for readmission _____________________________________________________________ NK
Is this a NIGHTINGALE or other SURGE FACILITY YES NO NK
Transfer from other facility YES-other facility is a study site YES-other facility is not a study site NO NK
If YES Name of transfer facility____________________________________________ NK
If YES Admission date at previous facility (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If YES-Study Site Participant ID at previous facility I__I I__I I__I I__I I__I -- I__I I__I I__I I__I
OR Same as above
VITAL SIGNS AT HOSPITAL ADMISSION (first available data at presentationAdmission ndash within 24 hours)
Temperature [_ ][_ ][_ ]degC HR [_ ][_ ][_ ]beats per minute RR [_ ][_ ]breaths per minute
Systolic BP [_ ] [_ ] [_ ]mmHg Diastolic BP [_ ][_ ][_ ]mmHg Severe dehydration YES NO NK
Sternal capillary refill time gt2seconds YES NO NK
Oxygen saturation [_ ][_ ][_ ] On Room air Any Oxygen therapy NK
Admission signs and symptoms (observedreported at admission and associated with this episode of acute illness)
History of fever
Cough
with sputum production
bloody sputumhaemoptysis
Sore throat
Runny nose (Rhinorrhoea)
Ear pain
Wheezing
Chest pain
Muscle aches (Myalgia)
Joint pain (Arthralgia)
Fatigue Malaise
Shortness of breath (Dyspnoea)
Disturbance or loss of taste (Ageusia )
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
Lower chest wall indrawing
Headache
Altered consciousnessconfusion
Seizures
Abdominal pain
Vomiting Nausea
Diarrhoea
Conjunctivitis
Skin rash
Skin ulcers
Lymphadenopathy
Bleeding (Haemorrhage)
If Bleeding specify site(s)
Disturbance or loss of smell (Anosmia)
None
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
________________________
YES NO NK
YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
CASE REPORT FORMS FRONT PAGE 3 of 3
Complete every line of every section except for where the instructions say to skip a section based on
certain responses
Selections with square boxes () are single selection answers (choose one answer only) Selections
with circles (o) are multiple selection answers (choose as many answers as are applicable)
Some fields are considered URGENT AND ESSENTIAL These are marked BOLD AND UNDERLINED
IN ALL CIRCUMSTANCES PLEASE PRIORITISE THESE DATA POINTS FOR URGENT UPLOAD
Mark lsquoNKrsquo for any results of laboratory values that are not known or not available
Avoid recording data outside of the dedicated areas Sections are available for recording additional
information
We recommend writing clearly in black ink using BLOCK-CAPITAL LETTERS
Place an (X) when you choose the corresponding answer To make corrections strike through (-------)
the data you wish to delete and write the correct data above it Please initial and date all corrections
In the case of a participant transferring between study sites such as to a Nightingale Hospital or
other surge facility it is preferred to maintain the same Participant Identification Number across the
sites When this is not possible a new Participant Identification Number should be assigned the
transferred participant will be linked by their identifiable data
Please keep all of the sheets for a single participant together eg with a staple or participant-unique
folder
These three FRONT PAGES do not need to be retained
DO NOT SEND CRFs to anyone by email or post
See the training guide on how to send consent to CCPliverpoolacuk using [SECURE] encryption
The Dalhousie University Clinical Frailty Score is provided below for your reference
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK ADMISSION FORM page 1 of 4 Date of enrolment [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Site Location__________________________________
For Tier Zero date of enrolment is date on which the act of data collection started For Tier 1 amp 2 enrolment = date of consent
CLINICAL INCLUSION CRITERIA
Proven or high likelihood of infection with pathogen of Public Health Interest YES NO NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Experience of the following symptoms during this illness episode (one or more required for inclusion)
History of self-reported feverishness or measured fever of ge 38oC YES NO
Cough YES NO
Dyspnoea (shortness of breath) OR Tachypnoea YES NO
Clinical suspicion of Acute Respiratory Infection despite not meeting criteria above YES NO respiratory rate ge50 breathsmin for lt1 year ge40 breathsmin for 1-4 years ge30 breathsmin for 5-12 years ge20 breathsmin for ge13 years
NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Adult or child who meets Case Definition for Inflammatory Multi-system Syndrome YES NO NB This group should be recruited regardless of covid-19 test as this syndrome can occur after mild disease in the community which has gone untested
DEMOGRAPHICS
Sex at Birth Male Female Not specified Date of birth [_D_][_D_][_M_][_M_][_ Y _][_ Y _][_Y_][_Y_] If date of birth is Not Known (NK) record Age [___][___][___]years OR [___][___]months Postcode [___][___][___][___] [___][___][___] England amp Wales NHS number Scotland CHI [___][___][___] [___][___][___] [___][___][___][___] NB Northern Ireland Health amp Care Number is not being collected at this time
Ethnic group (check all that apply)
oArab oBlack oEast Asian oSouth Asian oWest Asian oLatin American oWhite oAboriginalFirst Nations
oOther ________________________ NK
Employed as a Healthcare Worker YES NO NK
Pregnant YES NO NK If YES Gestational weeks assessment [___][___] weeks POST PARTUM (within six weeks of delivery) YES NO or NK (skip this section - go to INFANT)
Pregnancy Outcome Live birth Still birth Delivery date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Has infant(s) been tested for Motherrsquos infection YES NO NK If YES Positive Negative
IF POSITIVE PLEASE COMPLETE A SEPARATE CASE REPORT FORM FOR THE INFANT(s)
INFANT ndash Less than 1 year old YES NO (skip this section) Birth weight [___][___]kg NK
Gestational Term birth (ge37wk GA) Preterm birth (lt37wk GA) if lt37wk Estimated gestation ________weeks NK
Breastfed YES NO NK If YES Currently breastfed Breastfeeding discontinued NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 2 of 4
ONSET AND ADMISSION
Symptom onset date of firstearliest symptom [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] OR Asymptomatic
Admission date at this facility [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Is the patient being readmitted with Covid-19 YES NO NK
Please provide reason for readmission _____________________________________________________________ NK
Is this a NIGHTINGALE or other SURGE FACILITY YES NO NK
Transfer from other facility YES-other facility is a study site YES-other facility is not a study site NO NK
If YES Name of transfer facility____________________________________________ NK
If YES Admission date at previous facility (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If YES-Study Site Participant ID at previous facility I__I I__I I__I I__I I__I -- I__I I__I I__I I__I
OR Same as above
VITAL SIGNS AT HOSPITAL ADMISSION (first available data at presentationAdmission ndash within 24 hours)
Temperature [_ ][_ ][_ ]degC HR [_ ][_ ][_ ]beats per minute RR [_ ][_ ]breaths per minute
Systolic BP [_ ] [_ ] [_ ]mmHg Diastolic BP [_ ][_ ][_ ]mmHg Severe dehydration YES NO NK
Sternal capillary refill time gt2seconds YES NO NK
Oxygen saturation [_ ][_ ][_ ] On Room air Any Oxygen therapy NK
Admission signs and symptoms (observedreported at admission and associated with this episode of acute illness)
History of fever
Cough
with sputum production
bloody sputumhaemoptysis
Sore throat
Runny nose (Rhinorrhoea)
Ear pain
Wheezing
Chest pain
Muscle aches (Myalgia)
Joint pain (Arthralgia)
Fatigue Malaise
Shortness of breath (Dyspnoea)
Disturbance or loss of taste (Ageusia )
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
Lower chest wall indrawing
Headache
Altered consciousnessconfusion
Seizures
Abdominal pain
Vomiting Nausea
Diarrhoea
Conjunctivitis
Skin rash
Skin ulcers
Lymphadenopathy
Bleeding (Haemorrhage)
If Bleeding specify site(s)
Disturbance or loss of smell (Anosmia)
None
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
________________________
YES NO NK
YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK ADMISSION FORM page 1 of 4 Date of enrolment [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Site Location__________________________________
For Tier Zero date of enrolment is date on which the act of data collection started For Tier 1 amp 2 enrolment = date of consent
CLINICAL INCLUSION CRITERIA
Proven or high likelihood of infection with pathogen of Public Health Interest YES NO NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Experience of the following symptoms during this illness episode (one or more required for inclusion)
History of self-reported feverishness or measured fever of ge 38oC YES NO
Cough YES NO
Dyspnoea (shortness of breath) OR Tachypnoea YES NO
Clinical suspicion of Acute Respiratory Infection despite not meeting criteria above YES NO respiratory rate ge50 breathsmin for lt1 year ge40 breathsmin for 1-4 years ge30 breathsmin for 5-12 years ge20 breathsmin for ge13 years
NB For acute covid-19 please only collect data from proven (laboratory test-positive) people
OR
Adult or child who meets Case Definition for Inflammatory Multi-system Syndrome YES NO NB This group should be recruited regardless of covid-19 test as this syndrome can occur after mild disease in the community which has gone untested
DEMOGRAPHICS
Sex at Birth Male Female Not specified Date of birth [_D_][_D_][_M_][_M_][_ Y _][_ Y _][_Y_][_Y_] If date of birth is Not Known (NK) record Age [___][___][___]years OR [___][___]months Postcode [___][___][___][___] [___][___][___] England amp Wales NHS number Scotland CHI [___][___][___] [___][___][___] [___][___][___][___] NB Northern Ireland Health amp Care Number is not being collected at this time
Ethnic group (check all that apply)
oArab oBlack oEast Asian oSouth Asian oWest Asian oLatin American oWhite oAboriginalFirst Nations
oOther ________________________ NK
Employed as a Healthcare Worker YES NO NK
Pregnant YES NO NK If YES Gestational weeks assessment [___][___] weeks POST PARTUM (within six weeks of delivery) YES NO or NK (skip this section - go to INFANT)
Pregnancy Outcome Live birth Still birth Delivery date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Has infant(s) been tested for Motherrsquos infection YES NO NK If YES Positive Negative
IF POSITIVE PLEASE COMPLETE A SEPARATE CASE REPORT FORM FOR THE INFANT(s)
INFANT ndash Less than 1 year old YES NO (skip this section) Birth weight [___][___]kg NK
Gestational Term birth (ge37wk GA) Preterm birth (lt37wk GA) if lt37wk Estimated gestation ________weeks NK
Breastfed YES NO NK If YES Currently breastfed Breastfeeding discontinued NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 2 of 4
ONSET AND ADMISSION
Symptom onset date of firstearliest symptom [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] OR Asymptomatic
Admission date at this facility [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Is the patient being readmitted with Covid-19 YES NO NK
Please provide reason for readmission _____________________________________________________________ NK
Is this a NIGHTINGALE or other SURGE FACILITY YES NO NK
Transfer from other facility YES-other facility is a study site YES-other facility is not a study site NO NK
If YES Name of transfer facility____________________________________________ NK
If YES Admission date at previous facility (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If YES-Study Site Participant ID at previous facility I__I I__I I__I I__I I__I -- I__I I__I I__I I__I
OR Same as above
VITAL SIGNS AT HOSPITAL ADMISSION (first available data at presentationAdmission ndash within 24 hours)
Temperature [_ ][_ ][_ ]degC HR [_ ][_ ][_ ]beats per minute RR [_ ][_ ]breaths per minute
Systolic BP [_ ] [_ ] [_ ]mmHg Diastolic BP [_ ][_ ][_ ]mmHg Severe dehydration YES NO NK
Sternal capillary refill time gt2seconds YES NO NK
Oxygen saturation [_ ][_ ][_ ] On Room air Any Oxygen therapy NK
Admission signs and symptoms (observedreported at admission and associated with this episode of acute illness)
History of fever
Cough
with sputum production
bloody sputumhaemoptysis
Sore throat
Runny nose (Rhinorrhoea)
Ear pain
Wheezing
Chest pain
Muscle aches (Myalgia)
Joint pain (Arthralgia)
Fatigue Malaise
Shortness of breath (Dyspnoea)
Disturbance or loss of taste (Ageusia )
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
Lower chest wall indrawing
Headache
Altered consciousnessconfusion
Seizures
Abdominal pain
Vomiting Nausea
Diarrhoea
Conjunctivitis
Skin rash
Skin ulcers
Lymphadenopathy
Bleeding (Haemorrhage)
If Bleeding specify site(s)
Disturbance or loss of smell (Anosmia)
None
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
________________________
YES NO NK
YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 2 of 4
ONSET AND ADMISSION
Symptom onset date of firstearliest symptom [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] OR Asymptomatic
Admission date at this facility [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_]
Is the patient being readmitted with Covid-19 YES NO NK
Please provide reason for readmission _____________________________________________________________ NK
Is this a NIGHTINGALE or other SURGE FACILITY YES NO NK
Transfer from other facility YES-other facility is a study site YES-other facility is not a study site NO NK
If YES Name of transfer facility____________________________________________ NK
If YES Admission date at previous facility (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If YES-Study Site Participant ID at previous facility I__I I__I I__I I__I I__I -- I__I I__I I__I I__I
OR Same as above
VITAL SIGNS AT HOSPITAL ADMISSION (first available data at presentationAdmission ndash within 24 hours)
Temperature [_ ][_ ][_ ]degC HR [_ ][_ ][_ ]beats per minute RR [_ ][_ ]breaths per minute
Systolic BP [_ ] [_ ] [_ ]mmHg Diastolic BP [_ ][_ ][_ ]mmHg Severe dehydration YES NO NK
Sternal capillary refill time gt2seconds YES NO NK
Oxygen saturation [_ ][_ ][_ ] On Room air Any Oxygen therapy NK
Admission signs and symptoms (observedreported at admission and associated with this episode of acute illness)
History of fever
Cough
with sputum production
bloody sputumhaemoptysis
Sore throat
Runny nose (Rhinorrhoea)
Ear pain
Wheezing
Chest pain
Muscle aches (Myalgia)
Joint pain (Arthralgia)
Fatigue Malaise
Shortness of breath (Dyspnoea)
Disturbance or loss of taste (Ageusia )
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
Lower chest wall indrawing
Headache
Altered consciousnessconfusion
Seizures
Abdominal pain
Vomiting Nausea
Diarrhoea
Conjunctivitis
Skin rash
Skin ulcers
Lymphadenopathy
Bleeding (Haemorrhage)
If Bleeding specify site(s)
Disturbance or loss of smell (Anosmia)
None
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
YES NO NK
________________________
YES NO NK
YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 3 of 4
Is the patient thought to be a member of a CLINICALLY EXTREMELY VULNERABLE GROUP
Solid organ transplant recipients YES NO NK
People with specific cancers YES NO NK
bull people with cancer who are undergoing active chemotherapy
bull people with lung cancer who are undergoing radical radiotherapy
bull people with cancers of the blood or bone marrow such as leukaemia lymphoma or myeloma who are at any stage of treatment
bull people having immunotherapy or other continuing antibody treatments for cancer
bull people having other targeted cancer treatments which can affect the immune system such as protein kinase inhibitors or PARP inhibitors
bull people who have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs
People with severe respiratory conditions including all cystic fibrosis severe asthma requiring daily oral steroid or injectable
maintenance therapy and severe chronic obstructive pulmonary requiring oxygen (COPD) YES NO NK
People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe
combined immunodeficiency (SCID) homozygous sickle cell) YES NO NK
People on immunosuppression therapies sufficient to significantly increase risk of infection YES NO NK
Women who are pregnant with significant heart disease congenital or acquired YES NO NK
CO-MORBIDITIES (existing prior to admission)
Chronic cardiac disease including congenital heart disease (not hypertension)
YES NO NK Obesity (as defined by clinical staff) YES NO NK
Hypertension (physician diagnosed) YES NO NK Diabetes and Type NO 1 2 NK
Chronic pulmonary disease (not asthma) YES NO NK Diabetes (any) with complications YES NO NK
Asthma (physician diagnosed) YES NO NK Diabetes (any) without complications YES NO NK
Chronic kidney disease YES NO NK Rheumatologic disorder YES NO NK
Moderate severe liver disease YES NO NK Dementia YES NO NK
Mild liver disease YES NO NK Malnutrition YES NO NK
Chronic neurological disorder YES NO NK Smoking YES Never smoked Former smoker NK
Malignant neoplasm YES NO NK Other relevant risk factor
YES NO NK
If yes specify______________________________________
Chronic hematologic disease YES NO NK
AIDS HIV YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ADMISSION FORM Page 4 of 4
PRE-ADMISSION MEDICATION Were any of the following taken within 14 days of admission
Immunosuppressant eg oral (not inhaled) corticosteroids (not
low dose hydrocortisone) YES NO NK
Angiotensin converting enzyme inhibitors (ACEI)
YES NO NK
Angiotensin II receptor blockers (ARBs) YES NO NK
Non-steroidal anti-inflammatory (NSAID) YES NO NK Anti-infectives for this illness episode prior to admission
YES NO NK If yes specify______________
CLINICAL FRAILTY SCORE
With reference to the Dalhousie University Clinical Frailty Score (see guidance page 3 of complete CRF)
Clinical Frailty Score [___] value 1 to 9 or NK
CURRENT MEDICATION ON ADMISSION Record medication the patient is currently taking or has taken within the past 14 days
Medication name (generic name preferred)
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK DAILY
FORM complete per Tier of activity AND if research samples are collected Page 1 of 2
DAILY TREATMENT (complete every line)
DATE OF ASSESSMENT (DDMMYYYY) [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] Record the worst value between 0000 to 2400 on day of assessment (if Not Available write lsquoNKrsquo)
Is the patient in a high-level care area ie admitted to ICUITUIMCHDU YES NO NK
Highest Temperature [_ ][__][__] degC
Any Supplemental Oxygen YES NO NK FiO2 (021-10) [___][___][___] or [___][___] or [___][___] Lmin (highest)
Oxygen saturation YES NO NK SpO2 [___][___][___] (lowest)
AVPU Alert[___] Verbal[___] Pain [___] Unresponsive[___] or NK Glasgow Coma Score (GCS 15) [___][___] or NK
Is the patient currently receiving or has received (from 0000 to 2400) on day of assessment
Non-invasive respiratory support (eg NIV BIPAP CPAP) YES NO NK Invasive ventilation YES NO NK
High-flow nasal canula YES NO NK ECLSECMO YES NO NK
DAILY LABORATORY RESULTS
Record the values of laboratory results taken between 0000 to 2400 on day of assessment (if Not Available write lsquoNK if multiple record the values for the blood draw taken closest to middayrsquo)
Done YES NO NK Haemoglobin _______ gL or gdL
Done YES NO NK WBC count ___________ x109L or x103microL
Done YES NO NK Lymphocyte count ______________ ________ cells μL or x109L or x103microL
Done YES NO NK Neutrophil count _________________ _____ cells μL or x109L or x103microL
Done YES NO NK Platelets ___________ x109L or x103μL Done YES NO NK APTTAPTR ______
Done YES NO NK PT ___________ seconds or Done YES NO NK INR____________
Done YES NO NK ESR ___________ mmhr
Done YES NO NK Ferritin _________ microgL or ngmL
Done YES NO NK ALTSGPT _________ UL
Done YES NO NK Total Bilirubin _______micromolL or mgdL
Done YES NO NK ASTSGOT _________ UL
Done YES NO NK Glucose _________ mmolL or mgdL
Done YES NO NK Blood Urea Nitrogen (urea) ____________ mmolL or mgdL
Done YES NO NK Lactate ___________mmolL or mgdL
Done YES NO NK LDH [___][___][___][___]_UL
Done YES NO NK Creatinine Kinase (CPK) [___][___][___][___]_UL
Done YES NO NK Creatinine _____________ μmolL or mgdL
Done YES NO NK Sodium _____________ mmolL or mEqL
Done YES NO NK Potassium _____________ mmolL or mEqL
Done YES NO NK Procalcitonin [___][___][___][___]ngmL
Done YES NO NK CRP [___][___][___][___] mgL
Done YES NO NK eGFR _______ mLmin173 m2 oCKD-EPI oMDRD oCG
Most recent HbA1c______________ NK
Chest X-Ray CT performed YES NO NK IF Yes Were infiltrates present YES NO NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
DAILY FORM complete per Tier of activity AND if research samples are collected Page 2 of 2
RESEARCH SAMPLES
Where biological samples have been taken for research please record the KIT number here
KIT NUMBER [_C_] [_C_] [_P_] [_ _] [_ _][_ _][_ _][_ _]
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK
OUTCOME FORM Page 1 of 4
PATHOGEN TESTING
Was pathogen testing done during this illness episode YES NO NK
WERE THE FOLLOWING TESTS POSITIVE (PLEASE ENSURE FULL DETAILS OF TESTS ARE IN THE TABLE BELOW)
Influenza YES NO If YES AH3N2 AH1N1pdm09 AH7N9 AH5N1
A not typed other A _____________ B not typed Other type (specify)____________
NB Please do not enter Haemophilus influenza or parainfluenza above here ndash enter them under other below
Coronavirus YES NO If YES COVID-19SARS-CoV-2 2019
Other CoV (specify) _____________________
RSV YES NO
Adenovirus YES NO
Bacteria YES specify ___________________________ list all below No
Other YES NO If yes Other specify____________________________________________
On the form below please enter pathogen names in full without abbreviations
Collection Date (DDMMYYYY) Bio specimen Type Laboratory Test Method
Result Pathogen Detected
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
_____________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
__ __ __ __ 20__ __ NasalNP swab Throat swab
Combined nasalNP+throat swab
Sputum BAL ETA
Urine Fecesrectal swab
Blood
Other Specify
_____________________
PCR
Culture
Other Specify
______________
Positive
Negative
NK
______________
R
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 2 of 4
MEDICATION While hospitalised or at discharge were any of the following administered
Antiviral agent YES NO NK If YES tick all the apply oRibavirin oLopinavirRitonavir oInterferon alpha
oInterferon beta oChloroquine Hydroxychloroquine
oRemdesivir If YES first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
o IL6 inhibitor IF YES which Tocilizumab Anakinra Other IL6 inhibitor___________________
IL6 inhibitor first dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _] and last dose [_D_][_D_][_M_][_M_][_ Y _][_ Y _]
oNeuraminidase inhibitor if YES Which ________________ oOther antiviral _______________________________
Antibiotic YES NO NK If YES specify type(s) ________________ _____________ _____________
Corticosteroid YES NO NK If YES Route Oral Intravenous Inhaled
If YES please provide type name and maximum daily dose ___________
Dexamethasone 6mg once per day (od) YES NO NK If YES Route Oral Intravenous
Dexamethasone other dose _______mg
Dexamethasone other frequency oBD oTDS oQDS oOther ________________
Route Oral Intravenous
Antifungal agent YES NO NK If YES which ________________
Off-label Compassionate Use medications YES NO NK If YES which _____________________________________
Interleukin inhibitors YES NO NK If YES which ________________
Convalescent plasma YES NO NK
TREATMENT At ANY time during hospitalisation did the patient receiveundergo
ICU or High Dependency Unit admission YES NO NK If YES total duration _________days o still in ICUHDU
Date of ICUHDU admission[_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
ICUHDU discharge date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Any Oxygen therapy YES NO NK High-flow nasal canula YES NO NK
Non-invasive ventilation (eg BIPAP CPAP) YES NO NK
Invasive ventilation (Any intubation) YES NO NK If YES total duration _________days o still on
Prone Ventilation YES NO NK
Inhaled Nitric Oxide YES NO NK
Tracheostomy inserted YES NO NK
Extracorporeal (ECMO) support YES NO NK If YES total duration _________days o still on
Renal replacement therapy (RRT) or dialysis YES NO NK If YES total duration _________days o still on
Inotropesvasopressors YES NO NK If YES total duration _________days o still on
Blood Group (please check past as well as current medical record) oA oB oAB oO oNK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 3 of 4
COMPLICATIONS At any time during hospitalisation did the patient experience
Viral pneumonia YES NO NK Cardiac arrhythmia YES NO NK
Bacterial pneumonia YES NO NK Cardiac ischemia YES NO NK
Acute Respiratory Distress Syndrome
YES NO NK Cardiac arrest YES NO NK
Cryptogenic organizing pneumonia (COP)
YES NO NK Bacteraemia
YES NO NK
Pneumothorax YES NO NK Coagulation disorder
Disseminated Intravascular Coagulation
YES NO NK
Pleural effusion YES NO NK Anaemia YES NO NK
Bronchiolitis YES NO NK Rhabdomyolysis Myositis YES NO NK
Meningitis Encephalitis YES NO NK Acute renal injuryacute renal failure
YES NO NK
Seizure YES NO NK Gastrointestinal
haemorrhage
YES NO NK
Stroke Cerebrovascular accident YES NO NK Pancreatitis YES NO NK
Other neurological complication YES NO NK Liver dysfunction YES NO NK
Congestive heart failure YES NO NK Hyperglycaemia YES NO NK
Endocarditis YES NO NK Hypoglycaemia YES NO NK
MyocarditisPericarditis YES NO NK Other if yes specify below YES NO NK
Cardiomyopathy YES NO NK Other
STUDY PARTICIPATION
Is Has the participant being been recruited to a trial or multi-centre study during the period of their current illness (including
initiation in the community and hospital) YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID _______________________
Add another study YES NO IF YES specify Name of study_______________________________ Study Participant ID ______________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
OUTCOME FORM Page 4 of 4
OUTCOME
Outcome Discharged alive expected to survive
Hospitalisation = Remains in Hospital ge Day 28 after symptom onset
- if so Ongoing health care needs relating to this admission for COVID-19
OR
Medically fit for discharge (COVID-19 resolved) but remains in hospital for other reason (eg awaiting suitable care in community resident in long term health care or mental health facility)
Transfer to other facility Palliative discharge Death NK
Outcome date [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
If Discharged alive
Ability to self-care at discharge versus before illness Same as before illness Worse Better NK
If Discharged alive Post-discharge treatment
Oxygen therapy YES NO NK
If Transferred Facility name _____________________________________________________ NK
If Transferred Is the transfer facility a study site YES NO NK
If a Study Site Participant ID at new facility Same as above
Different [___][___][___][___][___]- [___][___][___][___] NK
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________
PARTICIPANT ID I___I I___I I___I I___I I___I -- I___I I___I I___I I___I
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK CCP-UK Case Report Form v96 06JULY2020
ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infections UK WITHDRAWAL FORM Page 1 of 1
WITHDRAWAL
Date of withdrawal [_D_][_D_][_M_][_M_][_2_][_0_][_Y_][_Y_] NK
Type of withdrawal Withdrawal from samples only Other Please specify ______________________________
Reason for withdrawal _____________________________________________________________________________